BioSpace News Archive

Policy

USGI Medical Receives FDA Approval to Conduct Pivotal Study of the POSE2.0® Incisionless Weight Loss Procedure for Primary Obesity

USGI Medical, Inc., the pioneer of incisionless weight loss procedures and devices, announced that the United States Food and Drug Administration has approved an Investigational Device Exemption application to conduct a pivotal study of its POSE2.0®incisionless procedure for primary obesity.

January 31, 2024
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4 min read
Pharm Country

Outlook Therapeutics® Doses First Subject in NORSE EIGHT

Outlook Therapeutics, Inc. today announced that the first subject has been dosed in the NORSE EIGHT clinical trial evaluating ONS-5010 in neovascular age-related macular degeneration (wet AMD) patients.

January 31, 2024
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6 min read
Pharm Country

LifeMD to Participate in the 11th Annual BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference

LifeMD, Inc. (Nasdaq: LFMD), a leading provider of virtual primary care, today announced its participation in the 11th Annual BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference, being held February 13-14, 2024 at the Cliff Lodge in Snowbird, Utah.

January 31, 2024
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1 min read
Crystal Pharmatech’s CDMO Business Unit - Crystal Formulations Services Successfully Passed EU QP Audit

Recently, Crystal Formulations Services, the CDMO Business Unit of Crystal Pharmatech has achieved a significant milestone by successfully passing the on-site audit conducted by the European Qualified Person, evaluating its GMP quality system and production facilities.

January 31, 2024
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2 min read
Pharm Country

Delcath Systems Receives Permanent J-Code (J9248) for HEPZATO™ (melphalan/Hepatic Delivery System) Effective April 1, 2024

Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced that the Centers for Medicare & Medicaid Services (“CMS”) has established a permanent and product-specific J-code (J9248) for HEPZATO.

January 31, 2024
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5 min read
FDA

W. L. Gore & Associates, Inc. Receives U.S. Food & Drug Administration (FDA) Approval for Lower Profile Gore® Viabahn® VBX Balloon Expandable Endoprosthesis, Now 6 FR Sheath Compatible

As part of efforts to continuously improve medical solutions for patients with complex vascular disease, W. L. Gore & Associates, Inc. announced recent FDA approval of a lower profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.

January 31, 2024
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4 min read
BioForest

Autoimmune Disease and Pregnancy: ISB Study Challenges Prevailing Wisdom, Unveils Nuances

An Institute for Systems Biology -led study showed nuanced pregnancy outcomes for pregnant individuals with autoimmune disease.

January 31, 2024
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4 min read
Biotech Bay

Pulse Biosciences Announces Preliminary Findings from its CellFX nsPFA 360 Cardiac Catheter First-In-Human Feasibility Study to be Featured in Podium Presentation at the AF Symposium

Pulse Biosciences, Inc. (Nasdaq: PLSE) today announced that its nsPFA technology will be featured in a podium presentation at the 29th Annual AF Symposium in Boston, Massachusetts, on February 2, 2024 at 10:00am ET.

January 31, 2024
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4 min read
Pharm Country

Savara to Present at Two Upcoming Healthcare Conferences

Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that its management team will be participating at the following investor healthcare conferences.

January 31, 2024
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1 min read
Business

Safecor Health Adds Eddie Carrillo as VP of Quality and Regulatory

Safecor Health today announced the addition of Eddie Carrillo as its newly-appointed Vice President of Quality and Regulatory.

January 31, 2024
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2 min read